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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04243837
Registration number
NCT04243837
Ethics application status
Date submitted
21/01/2020
Date registered
28/01/2020
Date last updated
23/04/2024
Titles & IDs
Public title
LYT-100 in Patients With BCRL
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Scientific title
A Phase 2a Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of Deupirfenidone (LYT-100) in Patients With Breast Cancer-Related Upper Limb Secondary Lymphoedema
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Secondary ID [1]
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LYT-100-2020-US-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer Related Lymphoedema
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Lymphoedema
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Condition category
Condition code
Cancer
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Breast
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LYT-100 BCRL
Treatment: Drugs - Placebo BCRL
Experimental: LYT-100 in patients with BCRL - LYT-100 BID for 6 months
Placebo Comparator: Placebo in patients with BCRL - Placebo BID for 6 months
Treatment: Drugs: LYT-100 BCRL
BCRL patients will receive LYT-100 BID for 6 months
Treatment: Drugs: Placebo BCRL
BCRL patients will receive Placebo BID for 6 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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Evaluate the safety and tolerability of LYT-100 as measured by TEAEs
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
Main
1. Female or male between 18 and 80 years old (inclusive) at the time of informed
consent.
2. At least 6 months since any type of breast cancer surgery (excluding fine needle
aspiration biopsy [FNA]), at the time of study screening. No intention to have breast
reconstructive surgery, nipple reconstruction and/or tattooing during the course of
the study.
3. At least 3 months since completion of all types of treatment for breast cancer,
including but not limited to neoadjuvant, radiotherapy, chemotherapy and
immunotherapy, at the time of study screening.
4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2
therapy at the time of screening, with no planned changes to this therapy throughout
the duration of the study.
5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast
cancer and/or metastasis for at least 6 months since breast cancer surgery, as
determined at screening and baseline.
6. Documented evidence of Stage 1 or 2 lymphedema.
7. Receiving standard of care compression or agreeable to using care compression, or no
compression at all = 4 weeks prior to screening and throughout the study.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e.,
sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or
lymphatic or vascular malformation, determined at screening.
2. Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs within 3 months prior to study drug
administration; corticosteroids are permitted at the discretion of the PI.
3. Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis,
dermatitis, necrotizing fasciitis, or current open wounds or sores in the affected
extremity.
4. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema
greater than 4 years, determined at screening.
5. Initiated use of compression or manual lymphatic drainage or other lymphoedema
therapies at the start of the study within 4 weeks of the screening visit. Rescreening
is allowed following a course of stable compression regimen of > 4 weeks.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/09/2022
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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University of the Sunshine Coast - Sippy Downs
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Recruitment hospital [2]
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Ballarat Health Services - Ballarat
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Recruitment hospital [3]
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Flinders University - Adelaide
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Recruitment hospital [4]
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Macquarie University Health Sciences Centre - Sydney
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Recruitment postcode(s) [1]
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- Sippy Downs
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Recruitment postcode(s) [2]
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- Ballarat
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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Georgia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
PureTech
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Novotech (Australia) Pty Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy
assessments, PK and biomarkers analysis in breast carcinoma patients with secondary
lymphoedema
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04243837
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04243837
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